DEPONIT 10MG/24 HOURS TRANSDERMAL PATCH

Main information

  • Trade name:
  • DEPONIT 10MG/24 HOURS TRANSDERMAL PATCH
  • Dosage:
  • 10 Mg/day
  • Pharmaceutical form:
  • Transdermal Patch
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • DEPONIT 10MG/24 HOURS TRANSDERMAL PATCH
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0365/088/002
  • Authorization date:
  • 30-10-2009
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PA0365/088/002

CaseNo:2072855

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

TransferredfromPA0271/007/002.

UCBPharmaLimited

208BathRoad,Slough,BerkshireSL13WE,UnitedKingdom

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

Deponit10mg/24hoursTransdermalPatch

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom30/10/2009.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

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Date Printed 30/10/2009 CRN 2072855 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Deponit10mg/24hoursTransdermalPatch

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachtransdermalpatchcontains37.4mgofglyceryltrinitrateinapatchsizeof18cm 2

,releasinganominal10mgof

glyceryltrintrateper24hours.

Forexcipients,seesection6.1.

3PHARMACEUTICALFORM

TransdermalPatch

White,translucentsquarepatchwithconvexroundcornerswith“deponit ®

10”markedontheouterface.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Prophylaxisofanginapectorisaloneorincombinationwithotheranti-anginaltherapy.

4.2Posologyandmethodofadministration

Adults:

Treatmentshouldbeinitiatedwithonepatchdaily.Ifnecessarythedosagemaybeincreasedtotwopatchesdaily.

Itisrecommendedthatthepatchisappliedtohealthy,undamaged;relativelycreasefreeandhairlessskin.Thebest

placestoapplyDeponitpatchesaretheeasilyreached,fairlystaticareasatthefrontorsideofthechest;however,

Deponitpatchesmayalsobeappliedtotheupperarm,thigh,abdomenorshoulder.Skincareproductsshouldnotbe

usedbeforeapplyingthepatch.Thereplacementpatchshouldbeappliedtoanewareaofskin.Allowseveraldaysto

elapsebeforeapplyingafreshpatchtothesameareaofskin.

Tolerancemayoccurduringchronicnitratetherapy.Toleranceislikelytobeavoidedbyallowingapatch-freeperiod

of8-12hourseachday,usuallyatnight.Anadditionalanti-anginaltherapywithdrugsnotcontainingnitrocompounds

shouldbeconsideredforthenitrate-freeintervalifrequired.

Aswithanynitratetherapy,treatmentwiththesepatchesshouldnotbestoppedabruptly.Ifthepatientisbeingchanged

toanothertypeoftreatment,thetwoshouldoverlap.

Elderly:

Nospecificinformationonuseintheelderlyisavailable;howeverthereisnotevidencetosuggestthatanalterationin

doseisrequired.

Children:

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4.3Contraindications

Knownhypersensitivitytonitratesortotheadhesivesusedinthepatch.

Acutecirculatoryfailure(shock,collapse).

Cardiogenicshock.

Raisedintracranialpressureincludingthatcausedbyheadtraumaorcerebralhaemorrhage.

Markedanaemia.

Closedangleglaucoma.

Hypotensiveconditionsandhypovolaemia.

Hypertrophicobstructivecardiomyopathy.

Aorticstenosisandmitralstenosis.

Constrictivepericarditis.

Cardiactamponade.

Concomitantuseofphosphodiesterasetype-5inhibitors.Phosphodiesterasetype-5inhibitors(e.g.sildenafil,tadalafil,

vardenafil)havebeenshowntopotentiatethehypotensiveeffectsofnitrates,andtheirco-administrationwithnitrates

ornitricoxidedonorsisthereforecontra-indicated.

4.4Specialwarningsandprecautionsforuse

Thispatchshouldbeusedwithcautioninpatientswith:

Severehepaticorrenalimpairment.

Hypothyroidism.

Hypothermia.

Malnutrition.

Arecenthistoryofmyocardialinfarction.

Hypoxaemiaoraventilation/perfusionimbalanceduetolungdiseaseorischaemicheartfailure.

Thepatchisnotindicatedforuseinacuteanginaattacks.Intheeventofanacuteanginaattack,sublingualtreatment

suchasasprayortabletshouldbeused.Aswithallnitratepreparationswithdrawaloflong-termtreatmentshouldbe

gradualbyreplacementwithdecreasingdosesoflongactingoralnitrates.

Ifthepatchesarenotusedasindicated(seesection4.2)tolerancetothemedicationcoulddevelop.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Concomitanttreatmentwithothervasodilators,calciumantagonists,angiotensinconvertingenzyme(ACE)inhibitors,

beta-blockers,diuretics,antihypertensives,tricyclicantidepressantsandmajortranquillisers,aswellastheconsumption

ofalcohol,maypotentiatethehypotensiveeffectofthepreparation.

Thebloodpressureloweringeffectofthesepatcheswillbeincreasedifusedtogetherwithphosphodiesteraseinhibitors

(e.g.sildenafil)whichareusedforerectiledysfunction(seecontraindications).Thismightleadtolifethreatening

cardiovascularcomplications.Patientswhoareonnitratetherapymustnotusephosphodiesteraseinhibitors(e.g.

sildenafil).

Ifadministeredconcurrently,thesepatchesmayincreasethebloodlevelofdihydroergotamineandleadtocoronary

vasoconstriction.

Thepossibilitythatingestionofacetylsalicylicacidandnon-steroidalanti-inflammatorydrugsmightdiminishthe

therapeuticresponsetothepatchcannotbeexcluded.

4.6Pregnancyandlactation

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Itisnotknownwhethertheactivesubstancepassesintobreastmilk.Benefitstothemothermustbeweighedagainst

risktothechild.

4.7Effectsonabilitytodriveandusemachines

Thesepatchesmayaffectthereactivityofthepatient.Patientsshouldnotdriveoroperatemachineryiftheirabilityis

impaired.

4.8Undesirableeffects

Averycommon(>10%ofpatients)adversereactiontothepatchisheadache.Theincidenceofheadachediminishes

graduallywithtimeandcontinueduse.

Atstartoftherapyorwhenthedosageisincreased,hypotensionand/orlight-headednessonstandingareobserved

commonly(i.e.in1-10%ofpatients).Thesesymptomsmaybeassociatedwithdizziness,drowsiness,reflex

tachycardia,andafeelingofweakness.

Infrequently(i.e.inlessthan1%ofpatients),nausea,vomiting,flushingandallergicskinreaction(e.g.rash),which

maybeseverecanoccur.Insinglecasesexfoliativedermatitismayoccur.

Severehypotensiveresponseshavebeenreportedfororganicnitratesandincludenausea,vomiting,restlessness,pallor

andexcessiveperspiration.

Uncommonlycollapsemayoccur(sometimesaccompaniedbybradyarrhythmiaandsyncope).Uncommonlysevere

hypotensionmayleadtoenhancedanginasymptoms.

Afewreportsofheartburn,mostlikelyduetoanitrate-inducedsphincterrelaxation,havebeenrecorded.

Allergicskinreactionstoglyceryltrinitrateandingredientscanoccur,buttheyareuncommon(i.e.>0.1%but<1%).

Patientsmaycommonlyexperienceslightitchingorburningatthesiteofapplication.Slightreddeningusually

disappearswithouttherapeuticmeasuresafterthepatchhasbeenremoved.Allergiccontactdermatitisisuncommon.

Duringthetreatmentwiththesepatches,atemporaryhypoxaemiamayoccurduetoarelativeredistributionofthe

bloodflowinhypoventilatedalveolarareas.Particularlyinpatientswithcoronaryarterydiseasethismayleadtoa

myocardialhypoxia.

4.9Overdose

Inviewofthetransdermalmodeofdelivery,anoverdoseofglyceryltrinitrateisunlikelytooccur.However,inthe

unlikelyeventofanoverdose,thesymptomscouldincludethefollowing:

Fallinbloodpressure 90mmHg.

Paleness.

Sweating.

Weakpulse.

Tachycardia.

Flushing.

Light-headednessonstanding.

Headache.

Weakness.

Dizziness.

Nausea.

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Methaemoglobinaemiahasbeenreportedinpatientsreceivingotherorganicnitrates.Duringglyceryltrinitrate

biotransformationnitriteionsarereleased,whichmayinducemethaemoglobinaemiaandcyanosiswith

subsequenttachypnoea,anxiety,lossofconsciousnessandcardiacarrest.Itcannotbeexcludedthatanoverdose

ofglyceryltrinitratemaycausethisadversereaction.

Inveryhighdosestheintracranialpressuremaybeincreased.Thismightleadtocerebralsymptoms.

Generalprocedure:

Stopdeliveryofthedrug.

Sincethesepatchesareappliedtotheskin,removingthepatchimmediatelystopsdeliveryofthedrug.

Generalproceduresintheeventofnitrate-relatedhypotension:

Patientshouldbekepthorizontalwiththeheadloweredandlegsraised.

Supplyoxygen.

Expandplasmavolume.

Forspecificshocktreatmentadmit.

patienttointensivecareunit.

Specialprocedure:

Raisingthebloodpressureifthebloodpressureisverylow

Treatmentofmethaemoglobinaemia

ReductiontherapyofchoicewithvitaminC,methylene-blue,ortoluidine-blue.

Administeroxygen(ifnecessary).

Initiateartificialventilation.

Redbloodcellorexchangetransfusion.

Resuscitationmeasures:

Incaseofsignsofrespiratoryandcirculatoryarrest,initiateresuscitationmeasuresimmediately.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

ATCCode:C01DA02,Vasodilatorsusedincardiacdiseases,organicnitrates.

Themainpharmacologicalactivityoforganicnitratesistherelaxationofsmoothvascularmuscles.Thesystemic

vasodilationinducesanincreaseofvenouscapacitance.Venousreturnisreduced.Ventricularvolume,fillingpressures

anddiastolicwalltensionarediminished(preloadreduction).

Adiminishedventricularradiusandreducedwalltension,lowermyocardialenergyandoxygenconsumption,

respectively.

Thedilationofthelargearteriesneartheheartleadstoadecreaseinboththesystemic(reductionofafterload)andthe

pulmonaryvascularresistance.Inaddition,thisrelievesthemyocardiumandlowersoxygendemands.

Bydilatingthelargeepicardialcoronaryarteries,glyceryltrinitrateenhancesbloodsupplytothemyocardium,

improvingitspumpfunctionandincreasingtheoxygensupply.

Atmolecularlevel,nitratesformnitricoxide(NO),whichcorrespondstothephysicalEDRF(endotheliumderived

relaxingfactor).EDRFmediatedproductionofcyclicguanosinemonophosphate(CGMP)leadstorelaxationofsmooth

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5.2Pharmacokineticproperties

(a) Generalcharacteristicsoftheactivesubstance:

Thetransdermalabsorptionofglyceryltrinitratecircumventstheextensivehepaticfirstpassmetabolismsothebio-

availabilityisabout70%ofthatachievedafteri.v.administration.

Thesteady-stateconcentrationintheplasmadependsonthepatchdosageandthecorrespondingrateofabsorption.At

arateofabsorptionof0.4mg/h,thesteady-stateconcentrationisabout0.2micrograms/lonaverage.Plasmaprotein

bindingisabout60%.Glyceryltrinitrateismetabolizedto1,2-and1,3-dinitroglycerols.Thedinitratesexertless

vasodilatoryactivitythanglyceryltrinitrate.Thecontributiontotheoveralleffectisnotknown.Thedinitratesare

furthermetabolizedtoinactivemononitrates,glycerylandcarbondioxide.

Theeliminationhalf-lifeofglyceryltrinitrateis2-4min.Themetabolismofglyceryltrinitrate,whichiseffectedinthe

liver,butalsoinmanyothercells,e.g.theredbloodcells,includestheseparationofoneormorenitrategroups.

Inadditiontothemetabolismofglyceryltrinitrate,thereisarenalexcretionofthecatabolites.

(b) Characteristicsinpatients:

Thereisnoevidencethatadosageadjustmentisrequiredintheelderlyorindiseasessuchasrenalfailureorhepatic

insufficiency.

5.3Preclinicalsafetydata

Glyceryltrinitrateisawell-knownsubstance,establishedformorethanahundredyears.Thusnewpreclinicalstudies

havenotbeencarriedoutwithDeponit10.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Acrylate/vinylacetateco-polymer

Polypropylenebackingfoil

Siliconisedpolyethylenereleaseliner

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

4years.

6.4Specialprecautionsforstorage

Donotstoreabove25 °

6.5Natureandcontentsofcontainer

Multilaminatepaper/polyethylene/aluminium/surlynsachetcontainingasinglepatch.28transdermalpatchesina

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6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

UCBPharmaLimited

208BathRoad

Slough

BerkshireSL13WE

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

PA0365/088/002

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:16February1996

Dateoflastrenewal:16February2006

10DATEOFREVISIONOFTHETEXT

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